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Analyst, QC I

Company: Planet Pharma
Location: Novato
Posted on: June 12, 2021

Job Description:

  • Perform, under direct supervision, chemical analyses of incoming raw materials under cGMP to meet specified timelines.
  • Evaluate results and trend data.
  • Maintain raw materials log and control of laboratory inventories.
  • Coordinate and track outside laboratory testing activities.
  • Participate in the preparation of investigations, summaries and reports.
  • Maintain the laboratory in an inspection ready state.
  • Must have a quality service attitude and be willing to work additional hours to meet production or laboratory requirements when necessary.
  • On rare occasion, provide on call coverage to perform off-shift emergency testing in support of manufacturing.
  • Other duties assigned.

Requirements:

  • EDUCATION B.S./B.A. in Science (major in biology-biochemistry-chemistry or related field) with at 0 - 1 years of relevant laboratory experience or A.S. with at least 2 years of relevant laboratory experience.
  •  Must have a positive, team minded personality
  • At least one year in a cGMP laboratory and quality control experience preferred, but not required.
  • Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices preferred
  • Demonstrated working knowledge related to specific functional activities.
  • Ability to perform most tasks with moderate supervision.
  • Computer literacy is required.
  • Experience with Microsoft Word and Excel required; experience with Labware LIMS, O365 a plus.
  • Must have excellent record keeping, written and verbal skills.
  •  Work in a GMP laboratory and be compliant with the laboratory procedures.
  • May work with biohazardous materials, hazardous chemicals, and radioactive materials.
  • Comfortable lifting 50 pounds.
  • Ability to work independently and to deal with multiple tasks.
  • May be required to work second shift, overtime, weekends and holidays.
  • Moderate supervision and minimal guidance should only be necessary for specific ad hoc assignments.
  • Organizational skills as well as good written and verbal communication skills essential.
  • Must work effectively as a member of the BioMarin team.
  • Must have a Quality service attitude and be willing to work additional hours to meet deadlines and requirements.   

Desired Skills:

  • Experience in a cGMP laboratory; quality control experience preferred.
  • Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices preferred
  • Familiarity/experience with Compendial testing (USP, EP, JP) preferred
  • Familiarity/experience with Labware LIMS preferred

Keywords: Planet Pharma, Novato , Analyst, QC I, Other , Novato, California

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